Healing Outcomes Following Hydraulic Condensation With a Bioactive Bioceramic Sealer in Root Canal Treatment

Not Applicable

Completed

• Conditions: Irreversible Pulpitis; Apical Periodontitis

• Registration Number: NCT07075354
• Lead Sponsor: Plovdiv Medical University

Brief Summary

This prospective clinical study aimed to evaluate the healing outcomes after root canal treatment using a bioceramic sealer called BioRoot RCS in combination with a technique known as hydraulic condensation. Root canal treatment is a common procedure used to remove infection and preserve teeth. Bioceramic materials have recently gained attention due to their ability to support natural healing, form a strong seal in the root canal, and stimulate tissue regeneration.

A total of 66 permanent teeth from patients diagnosed with either irreversible pulpitis or apical periodontitis were treated and followed over a 12-month period. All treatments were completed in a single visit and followed a standardized protocol using sonic irrigation and a calibrated drying method. The sealer used-BioRoot RCS-is a bioactive, calcium silicate-based material that hardens in the presence of moisture and promotes healing.

Patients were monitored clinically and radiographically using the Periapical Index (PAI), which is a scale that measures the status of periapical tissue (area around the root tip). Healing was considered successful if the treated teeth remained symptom-free and showed favorable radiographic changes over time.

Detailed Description

This prospective single-arm clinical study was designed to evaluate the healing outcomes following root canal treatment performed using a calcium silicate-based bioceramic sealer (BioRoot™ RCS) in conjunction with the hydraulic condensation obturation technique. The protocol emphasized clinical standardization, with all treatments completed in a single visit by experienced endodontists under magnification.

Following local anesthesia and rubber dam isolation, root canals were prepared using rotary nickel-titanium instrumentation to a standardized apical size (generally ISO 35-45 depending on canal anatomy), and irrigation was performed with 5.25% sodium hypochlorite (NaOCl) activated with a sonic device (EndoActivator, Dentsply Sirona). A final rinse protocol included 17% EDTA and saline, followed by calibrated drying with a single paper point to ensure optimal moisture conditions for the setting of the bioceramic sealer.

BioRoot RCS was mixed according to the manufacturer's instructions and delivered into the canals using a dedicated syringe tip. A single-cone gutta-percha point matching the apical preparation size was inserted with slight apical pressure to displace excess sealer, completing the hydraulic condensation process. No thermoplasticized techniques or heat sources were used to preserve the bioactive potential of the sealer.

Postoperative radiographs were taken immediately and at recall intervals of 6 and 12 months. Clinical and radiographic evaluations were conducted using the Periapical Index (PAI), with scoring by two calibrated examiners blinded to the clinical data. Inter-examiner agreement was assessed using Cohen's kappa.

The primary endpoint was periapical healing, operationally defined as a reduction in PAI score and the absence of symptoms. Comparative analysis was also performed between teeth with and without baseline periapical pathology to assess differential healing responses.

Study Timeline

• Study Start: 2021-01-20
• Primary Completion: 2022-01-20
• Study Completion: 2022-01-20
• Status Verified: 2025-07
• Study First Submitted: 2025-07-01
• Study First Submitted QC: 2025-07-10
• Study First Posted: 2025-07-20
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Periapical Healing Assessed by Periapical Index (PAI) Score	Baseline, 6 months, and 12 months post-treatment	Radiographic assessment of periapical healing using the Periapical Index (PAI) scoring system on standardized periapical radiographs. Successful healing is defined as a reduction in PAI score indicating resolution or significant improvement of apical periodontitis.

Trial Locations

Locations (1)

Medical University of Plovdiv, Faculty of Dental Medicine, Department of Operative Dentistry and Endodontics; 🇧🇬 Plovdiv, Plovdiv Region, Bulgaria